Recruiting

Cognitive-Behavioral Therapy vs. Mindfulness-Based Therapy

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06060860

Conditions

Autism Spectrum Disorder

Depression

Anxiety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive-Behavioral Therapy (CBT)

Mindfulness-Based Cognitive Therapy (MBCT)

Study Details

Brief summary:

Autistic adults are at a greater risk for mental health problems compared to the general population, with 50% meeting criteria for a co-occurring psychiatric condition. Depression and anxiety are the most common of these conditions among autistic adults, contributing to long-term detrimental effects on health, day-to-day functioning, and quality of life. This study will conduct the first large-scale head-to-head comparison of the two most widely studied mental health interventions for autistic adults: cognitive-behavioral therapy (CBT) and mindfulness-based therapy (MBT). Both interventions are well-established, empirically supported treatments for depression and anxiety in the general population, and both interventions have demonstrated efficacy among autistic adults. However, their comparative effectiveness and heterogeneity of treatment effects have not been established in autistic adults. Both interventions will be delivered by telehealth.

Conditions

Autism Spectrum Disorder

Depression

Anxiety

Study ID

NCT06060860

Start date

Jan 17, 2024

Status verified date

Sep, 2025

Completion date

Feb 15, 2027

Anticipated

Primary completion date

Aug 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥18 years of age
  • Co-occurring depression and/or anxiety as determined by a total score ≥10 on the PHQ-ADS
  • Living in North Carolina or Virginia
  • Ability to participate in therapy sessions over telehealth
  • English-speaking
  • Provide proof of a professional diagnosis of autism OR meet or exceed clinical cut-off on the Social Responsiveness Scale (SRS-2) autism screening instrument

Exclusion Criteria:

  • Altered mental status that precludes the ability to provide informed assent or consent (acute psychosis, intoxication, or mania)
  • Imminent risk of suicide

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Cognitive-Behavioral Therapy (CBT)

The arm receives the Unified Protocol (UP), a modular transdiagnostic CBT treatment that uses a parsimonious approach to treatment by addressing common emotion-related mechanisms underlying both anxiety and depression.

active comparator: Mindfulness-Based Cognitive Therapy (MBCT)

Mindfulness-Based Cognitive Therapy (MBCT) is an empirically supported treatment that focuses on non-judgmental acceptance of present moment experiences and emotions. MBCT was adapted from Mindfulness-Based Stress Reduction (MBSR) to focus on improving mental health more specifically in individuals with depression and other psychiatric conditions.

Interventions

Cognitive-Behavioral Therapy (CBT)

The UP incorporates common principles among empirically supported CBT protocols, including restructuring maladaptive cognitions, changing maladaptive behaviors, preventing emotion avoidance, and incorporating exposure. It consists of five core treatment modules:

1. emotion awareness,
2. cognitive appraisal \& reappraisal,
3. emotion avoidance \& emotion-driven behaviors,
4. awareness and tolerance of emotion-related physical sensations, \&
5. interoceptive and situational emotion-focused exposures.

There are two introductory modules on enhancing motivation and understanding of emotional experiences. A final module is on maintenance and relapse prevention. Modules are delivered at a flexible pace and some patients may spend multiple sessions on the same module. The total number of sessions varies from patient to patient, generally ranging from 12-18 sessions (50-60 minutes) delivered weekly. All sessions are 1:1 via telehealth.

Mindfulness-Based Cognitive Therapy (MBCT)

The study MBCT protocol is a 9-week program (90-120 minute sessions) with home-based practice between sessions. MBCT sessions incorporate formal mindfulness meditation practices such as sitting meditation, mindful movement, and body scan (with a focus on mindful and non-judgmental attention to sensations, thoughts, and feelings), as well as informal practices and homework to integrate mindful awareness into everyday life, such as mindful eating, mindful walking, and mindful breathing. All sessions are 1:1 via telehealth.

Primary outcome measure

  • Change in anxiety and depression symptoms [ Time Frame: Baseline, up to 18 weeks ]

Central Contacts and Locations

Central contacts

Laura Klinger, PhD

(919) 966-8183laura_klinger@med.unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27510

Contacts

Laura Klinger, PhD

919-966-8183laura_klinger@med.unc.edu

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Micah Mazurek, PhD

434-924-5692mm5gt@virginia.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

Keywords

  • autism spectrum disorder
  • depression
  • anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2025-09-18.